This invention is designed to help patient who suffer from rectal incontinence. People who suffer from rectal incontinence have an inability to control the muscles that control the evacuation of feces via the anal canal. The aim of any product in this classification of medical devices, especially the device disclosed herein, is to reduce or eliminate the amount of fluid or secretions created by the bowel or stool in those who cannot physically control their bodily functions themselves. The fecal matter and associated fluids can also be created by conditions in which are abnormal such as: Crohns disease, ulcertive colitis, and diarrhea sometimes caused by Giardia found in untreated water. The anus is almost incapable of holding fine fluid even for a normal person who does not suffer from Rectal incontinence. Incontinence can also be caused by spinal cord injury, Parkinson's, multiple sclerosis, traumatic brain injury, complications post-surgery, childbirth especially as a result of episiotomy, treatment of the pelvic area with chemotherapies and/or radiation in cancer patients, infections and other causes. Incontinence can also be caused by cognitive/mental disabilities such as severe mental retardation, and severe autism. Due to the nature of the design of this device, and its method for use, this device is also applicable in animals in certain cases as well as in humans.
This invention also has its uses during the embalming and postmortem procedures where leakage is a common occurrence with the buildup of gases and fluids in the body which will eventually escape through the natural orifices as the pressure builds.
In a healthy subject, one's fecal continence is controlled by the voluntary constriction of the external and internal anal sphincters which is a circular band of muscle surrounded by a two flattened planes of muscular tissue and the associated constriction of the interior anal sphincter via its set of muscular tissues surround the anal canal. These muscles are always in a state of tonic contraction but yet have no antagonist muscles to oppose the sphincter muscles that act in opposition to the specific movement generated by the sphincter muscles. The muscles can be further constricted by voluntary movement of the subject causing a further occlusion of the anus, the last area of sealing controlled by the external and internal anal sphincters to prevent accidental discharge.
The anus is the last part of the intestinal tract. It is the final orifice through which stool passes out of the body. The lower half of the anal canal has sensitive nerve endings. There are blood vessels under the lining, and in its mid portion there are numerous tiny, anal glands. There are visceral nerves inside of the anal canal, which are sensory motor nerves, which feel only pressure. This gives the sensation of fullness and therefore one defecates once a certain pressure is reached. Somatic nerves, one of the nerves of parietal sensation or voluntary motion, are located on the exterior of the anal canal and anus and can feel pressure as well as pain. Due to the density of nerves in this region, it is especially important not to have a device that increases pain and discomfort.
The prior art is replete with devices that are used to control anal leakage and can be broken down into three basic categories; 1) devices that are designed to catch the fecal matter as there is no control of the process, 2) devices that attempt to simulate the action of the sphincter muscles and 3) devices meant to stem the tide of the leakage by placing devices into the rectal cavity.
Devices in category one include absorbent undergarments, such as adult diapers or waterproof pants or shorts with liners that can absorb liquid matter. These are mostly designed for uniform solid matter. Some of these garments come with reservoirs to hold the solid matter, but this, only increases the bulkiness and decrease the comfort and ease of use when these reservoirs are attached. These garments are already very uncomfortable and bulky to begin with. Physical movement, let alone exercise, and inability to discretely carry multiple diapers, is greatly limited as these garments are not designed for movements of the legs and pelvis, or they are so restrictive that they prevent normal activities, such as walking, running, swimming and intimacy. In addition, the traditional diaper holds fecal material as stated above, therefor placing the patient at risk for skin breakdown, foul odor and pain. Thinner absorbent pads can be used, such as panty liners, but are not appropriate for anal incontinence as the pads are hard to locate retro-anally into undergarments as the garments will shift between standing and sitting to laying and/or walking positions of the users, thereby creating a false sense that the pads will be in the proper location to absorb. Some pads or patches are adhesively adhered to the user. U.S. Pat. No. 8,353,884 issued to Hansen et al on Jan. 15, 2013 and U.S. Pat. No. 7,195,619 issued to Manasek on Mar. 27, 2007 typify the types of absorbent pads or patches that are available. Both are to be placed onto the garments but by their shape and design, they are capable of being located into a close proximity of the anus and are designed to catch the leakage as it is directed into the pad where absorbent material. The '884 patent provides for a two part device where the absorbent pad is unattached to the flanged part which has the advantages of sealing more closely to the anus and addresses the issues regarding the movement of the pad during exercise and simple movements but is confined to those “low-level incontinence” as those without any control of their bowels will have a much heavier flow at times thereby inundating the pads beyond their capacity.
Another example of this style of pads are designed to prevent the flow from exiting by closely fitting into the perineum region by fitting within the intergluteal or natal cleft, being held in place through the use of adhesives (U.S. Pat. No. 5,695,484 issued to Cox on Dec. 9, 1997) or by contouring an absorbent pad into a shape that coincides with the shape of the individual's intergluteal region. Both of these patents approach the problem of leakage uniquely but still have problems similar to the aforementioned prior art. The pads are difficult to place into the correct region, adhesives are difficult to adhere to often hairy skin areas, perspiration and movement by the user can dislodge the pad easily and will cause embarrassing and unsanitary leakage.
Prior art discloses devices that try to eliminate the leakage from either trying to trick the body into closing their sphincter muscles or have a mechanical means to accomplish the same result. U.S. Pat. No. 7,360,544 issued to Levien on Apr. 22, 2008 details the insertion of a truncated cone and a straight tube with an angled concavity, which allegedly exploits the voluntary inhabitation action and/or simple closure of the anal slit to decrease facial incontinence or soiling whereby the contraction of the external sphincter muscles to hold the tube will cause a relaxation of the rectum thereby increasing the reservoir capacity of the rectum. This patent assumes that one has the control in the muscles but for some reason, one fails to utilize the control, but does not address those situations where one is without any muscle control of the anus or either of the sphincters. U.S. Pat. No. 5,593,443 issued to Cater et al on Jan. 14, 1997 details a surgical procedure where the action of the damaged sphincter muscle is replaced with an inflatable tube which simulates the sphincter closing off the exit of the rectum by crushing the walls of the lower rectum into the walls of the anal canal with a liquid filled strap from only side of the rectum. Patent Application 2007/0073099 with inventors Forsell published on Mar. 29, 2007, discloses another mechanical device which forcibly seals the anus, but uses a more natural constriction which is circular in nature more closely aligned with the actual functions of the body. The application also discloses alternate adoptions of the device in relation to the rectum and the anal canal. These drastic surgical methods where devices are implanted within the patient's body are invasive and can cause a host of issues from infections and tearing of the sensitive tissues of the rectum and anus, causing even more damage to the anus, along with repeated mechanical crushing of the tissues to simulate the actions of the sphincter. These surgical techniques and solutions are not intended for everyone and only a small percentage benefit for a period of time from which then, the patient must seek alternative aids. Furthermore, these techniques require anywhere from 4 to 6 months to show some type of relief in selected patients.
The third basic categories of device that control anal leakage are devices that are fitted into the rectal cavity and anal canal. A study reported in the European Journal of Pediatrics Surgery in June of 2000 entitled “A new polyurethane anal plug in the treatment of incontinence after anal atresia repair” detailed the efficacy of plastic plugs inserted into the rectal cavity. The study found that the anal plug was the only non-surgical treatment for fecal incontinence available to those patients who want to carry on a complete social life. U.S. Pat. No. 8,444,546 issued to Shalon et al on May 21, 2013 discloses two styles of anal plugs used to prevent incontinence. One style has an applicator inserting a “Y” shaped device which flattens out and seals against the walls of the anal canal. This problem with this style of device is that there is no means to control the position of the plug within the rectal area, let alone maintaining the position in the anal canal.. The British Journal of Nursing in November of 2004 discussed studies perform on a different style of anal plug called the Peristeen Anal Plug, developed originally as the Conveen Anal Plug, which is similar in design to the first iteration of the Shalon device. The journal discussed the positive results, but further clinical experience of others have found that this style of plug has no restriction on the migration of the plug deeper into the recesses of the rectum and further into bowel. There are no means to hold this device in the proper location, and as the user already has weakened or non-existent control of the sphincter muscles already, there is nothing to prevent the device from moving inward as the person moves and especially in the sitting position. In addition, the PU Conveen plug is not practical in the for of application. The user must use his/her fingers to properly insert the plug past the anal canal. This approach is unsanitary and discouraging for patients.
The second iteration of the Shalon patent discloses a plug that has a disk that has a diameter slightly greater than the anal canal, it is forced past the anus and both sphincter muscles, with either a two prong introducer or digitally placed, both of which have a much smaller diameter in relation to the diameter of the anal canal as shown in FIGS. 6B and 8C of Shalon. The other end of the plug has biasing cap which rests on the exterior of the anus. This biasing cap is to hold the plug in place, preventing the transiting of the plug further into the rectal cavity. The problem of maintaining location has been solved with a very draconian device in a very sensitive area. A person would have a stiff plastic unyielding stem or rod which is connected to a softer disc that have been forced past narrower canals in order to seal a larger canal in the sensitive anal canal. And since the stem connecting the two disks is not adjustable, the individual person is subjected to a norm to fit their particular body, subjecting the user to possible leakage past the lower seal should the connecting be too long for their particular body or the stem not thick enough to seal the anal canal itself. As the European Journal study did find that the plugs, even though made of a PVA or polyurethane material had painful inserts, due to the methods used to deploy these plugs, a feeling of uncomfortable pressure inside of the anal canal and painful plug removal due to the migration of the device inwardly and oversized plug as in the case of the PVA plug. Another study published in Cochrane Incontinence Group Specialized Register in 2012 found that anal plugs work if they can be tolerated and found that even though they are helpful in preventing incontinence, they can be difficult to tolerate due to the stiff and oversized material used. The group found that the rectal cavity must be trained over a few applications and with tolerable materials. The disposal of this device is also questionable as it would not be able to be flushed down the toilet forcing the user to deal with a bowel discharge while removing this device and making sure it does not go down the toilet, as well as having to find an appropriate disposal means.
It is an object of this invention to create a device that will prevent the anal leakage associated with incontinence. The device must be designed taking into account that every application is different in size and volume.
It is another object of this invention to create a device that will prevent anal leakage associated with incontinence that enables the person to carry on an active lifestyle without the worry of dislodgement or an embarrassing failure of the device, and furthermore, the device must provide comfort and flexible to prevent discomfort to the user.
It is further object of this invention to create a device that is comfortable in both the insertion, use and removal of said device from the very sensitive anal canal and rectal cavity, said device being developed with the knowledge that the insertion of the device will most likely be done by the user of the device. If nurse or caregiver is to apply device to patient, device allows for sanitary and non-digital intrusion for administration. This invention should not contain any sharp edges, or stiff connecting rods that cause discomfort, or places the user at risk for internal injury.
It is further object of this invention to allow the user to carry multiple units in a discrete fashion. The device is compact and can be carried in pant pocket or purse offering discretion and peace of mind knowing it's at their disposal.
Another object of this invention is to insure that the insertion means is never larger than the anus with minimal stretching of the anal canal during insertion.
It is a further object of this invention to create a device the is disposable and that can be removed and flushed down a toilet, reducing handling and disposal problems, since removal is likely to be associated with a bowel discharge. Good sanitary practice reduces the spread of microorganisms.
It is a further object of this invention to create a device that has application in all age groups and into fields beyond just human medicine, where animals can benefit from this device as the device should be easy to use, without painful insertion and prevent leakage in light of normal behavior.
It is a further object of this invention to have a device that has more than one sealing means to prevent anal leakage should the primary means not provide 100% protection.
It is a further object of this invention to have a device that has more than one functional means other than preventing anal leakage; it should also have a hemostatic benefit. On occasion post hemorrhoidectomy, some bleeding may occur internally in the proximal anal opening of internal anal canal region. Pressure placed on the internal region of bleeding area can reduce and cease the bleeding.